The Recall Desk
HighFDA (Devices)·Z-1459-2014·Announced 2014-04-23

CareFusion SmartSite Extension Set Recalled for Tubing Disconnections and Leaks

CareFusion 303, Inc. is recalling 7,700 SmartSite Extension Sets due to disconnections and leakages at the tubing and Y-port connection.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect (disconnections and leakages) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

CareFusion 303, Inc. is recalling 7,700 units of the SmartSite Extension Set, Model No. 20029E. This product is an intravascular administration set used for medical purposes.

The recall was initiated because of disconnections and leakages occurring at the connection between the smallbore tubing and the SmartSite Y-port. The affected units are identified by Lot No. 13085791.

The product was distributed nationwide in the United States, specifically in the states of AR, AZ, CA, CO, FL, ID, MD, MI, NC, NV, OK, OR, PA, TX, VA, and WI. Users should stop using the affected sets and contact the manufacturer for further instructions.

The recalled product

Product
SmartSite Extension Set, Model No. 20029E, intravascular administration set.
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Intravascular Administration Set
Hazard
Affected units
7,700

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot No. 13085791

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

Related recalls

Same manufacturer · CareFusion 303, Inc.

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Same hazard · leakage

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